Quality

From our world-class manufacturing facilities and R&D labs to our award-winning customer service teams, quality is KIK Custom Manufacturing’s (KCM) competitive advantage. When you award KCM with your contract business, we ensure products calibrated to your quality specifications every time.

Our plants are FDA-registered and strictly follow the industry’s current Good Manufacturing Practices (cGMPs). KCM regularly invests capital in each of our plants to ensure continuous improvement and required maintenance of buildings and equipment.

People are a critical part of the quality equation. KCM invests resources in recruiting and retaining only the best personnel in each of our plants. All employees are trained and strictly observe KCM’s quality standard operating procedures (SOPs). Customer specifications and standards are strictly upheld.


Quality and Compliance

KCM has been successful in meeting and exceeding the highest standards of Quality and Compliance required by our customers, the Food and Drug Administration (FDA), and Health Canada.


Quality Resources

KCM has both Operational and Quality leadership with extensive experience in manufacturing regulated products. Each facility has a site head of Quality, and the division provides Quality resources to manage common Quality Systems and Supplier Quality.


Quality Systems

KCM utilizes a Quality Systems approach to ensure compliance with regulations and customer requirements. Elements of KCM's Quality Systems include:

Corporate Quality Standards - Corporate Policies are approved by the KCM Executive Team, which includes the division President. These policies define the standard expectations that all KCM sites must meet with respect to quality and compliance.

SOPs - Standard Operating Procedures are in place at each site, using the KCM Quality Standards as their basis, but written specifically to match the technologies and product types at each facility.

Lot Control - All materials that are used in specific quantities are received, tested, released, and dispensed according to specific lot numbers. This allows for full control of materials and traceability. We understand the status of our raw materials, components, work-in-process, and finished products at all times.

Quality Control - Each of KCM's production sites contain analytical testing laboratories which provide site-specific raw material, packaging component, bulk product, and finished product testing, using state-of-the-art equipment, as required by our customers' specifications and/or USP or other compendia requirements. Microbiological laboratories are in place at our Cortland, Elkhart, Danville, and Rexdale sites to provide a high level of material control and ensure appropriate environmental monitoring of our facilities.

Method Development, Validation and Transfer - KCM has a Method Development, Validation and Transfer organization which can both develop new or transfer existing analytical methods, based on customer needs, and ensure that those methods are validated according to regulatory expectations.

Stability - KCM writes Stability protocols and conducts Stability testing for its customers. In the early stages of a project, these same capabilities are used to provide Material Compatibility data during the early formula and package development phases.

Validation and Qualification - KCM has Validation departments that provide Equipment Qualification, Computer System Validation, Process Validation, and Cleaning Validation support for all sites.

Change Control - Change Control boards at each location consider product, process, and equipment changes for the impact of such changes to the validated state of a customer's product. The Quality Assurance department manages the Change Control efforts at each site.

Corrective and Preventative Action (CAPA) Program and Trend Analysis - One of the most important elements of a strong Quality System is a robust CAPA program, where actions to solve and prevent recurrence of problems are developed and documented, and developing trends can be analyzed and rectified before they become larger issues that can affect supply assurance. KCM systematically tracks and trends CAPAs, and this trend analysis is shared in quarterly Management Review meetings. The effectiveness of prior, closed CAPAs is evaluated and monitored at the Management Review.

APRs - Providing a history and trending of regulated product through the annual product review process.

Complaint Management - Fully investigating complaints and trending of complaints to address product or process issues.

Quality Agreements - Clear communication and transparency are key to KCM and our customer relationships. To help ensure clear communication and eliminate confusion in roles and responsibilities, we routinely develop Quality Agreements with our customers. These agreements outline Quality System expectations and responsibilities between KCM and the customer, which streamlines communications and ensures that all compliance expectations are met.

Site Master Files - For products manufactured for shipment outside the U.S., KCM's Regulatory department maintains and can provide our customers with Site Master Files for each KCM location. This allows customers to successfully file KCM as the manufacturer of record in their international filings.

Supplier Qualification - In cases where KCM purchases materials, suppliers of these materials are evaluated and qualified using the KCM Supplier Qualification program. This program ensures that all suppliers meet the quality standard of KCM and our customers, ensuring continuous reliability of supply.

Supplier Technology Development - Analytical resources to problem solve formulation, raw material and/or component issues.


Quality Policy

KIK Custom Manufacturing (KCM) is committed to consistently meeting the expectations of our customers and the government agencies that regulate our products and facilities.

We achieve this goal by:

Building quality, safety and productivity into everything we do.

Implementing cGMP requirements and the necessary SOPs to support all requirements and remaining in an audit ready state at all times.

Protecting products from cross-contamination and/or mix-up.

Ensuring products are manufactured the same way every time through product validation and equipment qualification.

Implementing effective training programs and procedures that focus on continuous improvement and risk management.

Holding our employees accountable for excellence.

Holding our suppliers accountable for excellence, and ensuring compliance through auditing and tracking systems.

Instituting continuous improvement feedback derived from internal audits, external audits, complaints, CAPAs, and process control data through statistical trending.

Exercising relentless focus on product and process control improvements.